The U.S. Food and Drug Administration (FDA or the Agency) closed out 2011 with the release of two important documents—(i) a draft guidance on responding to unsolicited requests for off-label information and (ii) a Federal Register notice requesting comments on scientific exchange in the context of investigational and off-label uses.
Despite not being focused solely on social media, the new draft guidance ventures into previously uncharted territory by addressing how organizations should respond to individual comments made in public forums—including websites and blogs (even mentioning YouTube and Twitter by name)—in addition to those made during face-to-face meetings and speaking events, suggesting that this may be the first of what FDA has indicated will be a handful of guidances addressing social media–related issues. In addition, the issuance of these documents also signals that the Agency is cognizant of, and wants to appear responsive to, ongoing industry complaints that it has provided little in the way of useful guidance on dissemination of off-label information.
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